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Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel

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ClinicalTrials.gov Identifier: NCT01891383
Recruitment Status : Unknown
Verified December 2015 by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences.
Recruitment status was:  Recruiting
First Posted : July 3, 2013
Last Update Posted : January 1, 2016
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences

June 25, 2013
July 3, 2013
January 1, 2016
July 2013
June 2016   (Final data collection date for primary outcome measure)
Prevalence of dementia or MCI in the two groups (TBI versus no TBI) [ Time Frame: Single visit, 4 hours. ]
The primary outcome will be the prevalence of dementia/MCI in the two groups (i.e. those with and without a TBI).
Same as current
Complete list of historical versions of study NCT01891383 on ClinicalTrials.gov Archive Site
Characterization of the types of dementia or MCI that occur in the two groups (TBI or no TBI) [ Time Frame: Single visit, 4 hours. ]
The characterization of the dementia and cognitive impairment within the two groups based on the neuropsychological testing will be secondary outcomes of the study.
Same as current
Not Provided
Not Provided
 
Clinical Characteristics of Dementias That Occur Remotely After Traumatic Brain Injury in Retired Military Personnel
Endophenotypes of Dementia Associated With Traumatic Brain Injury in Retired Military Personnel
The objective of this study is to measure the frequency and clinical types of mild cognitive impairment (MCI) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (TBI) among residents of the Armed Forces Retirement Home, Washington D.C. and the Veterans Home of California-Yountville. Investigators will compare the characteristics of dementia in those who have had a prior TBI to the characteristics in those without a history of TBI. It is our hypothesis that the dementia or MCI among those with prior TBI has distinct neuropsychological features that distinguishes it from those with dementia or MCI without a history of TBI.
75 participants with a history of TBI will be the cases (exposed) group. A control group of 75 retirement home residents without a history of TBI who are age-matched to the cases will also be recruited. Participants will be evaluated in a single visit, which will include neurological, psychiatric, and cognitive assessment. The evaluation will take approximately 4 hours. In some cases, the evaluation may be split into two 2 hour sessions.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
Subjects for this study will be recruited from the Armed Forces Retirement Home (AFRH) in Washington, DC and the Veterans Home of California- Yountville. Up to 150 AFRH residents from both the independent living and the assisted living facilities will be invited to take the screening questionnaire and enroll in the study.
  • Dementia
  • Traumatic Brain Injury (TBI)
  • Mild Cognitive Impairment (MCI)
  • Chronic Traumatic Encephalopathy (CTE)
  • Post-traumatic Stress Disorder (PTSD)
Not Provided
  • History of TBI
    The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF).
  • No history of TBI
    The history of TBI will be assessed by the subject's answers to the Ohio State University Traumatic Brain Injury Identification Method Short Form (OSU TBI-ID SF).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
Same as current
August 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Cases (with a history of TBI):

  1. Ages 50-95 years
  2. History of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID, and based on DoD/VA criteria)
  3. Residence in AFRH-Washington D.C. or the Veterans Home of California-Yountville
  4. MMSE score ≥ 20
  5. Capacity to provide consent to participate in research (assessment made by study physician)
  6. Ability to read and write English

Controls (without a history of TBI):

  1. Ages 50-95 years
  2. No history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the Ohio State University TBI Identification Questionnaire—OSU TBI-ID)
  3. Residence in AFRH-Washington or the Veterans Home of California-Yountville
  4. MMSE score ≥ 20
  5. Capacity to provide consent or assent to participate in research
  6. Ability to read and write English -

Exclusion Criteria:

Cases (with a history of TBI):

  1. History of penetrating brain injury
  2. History of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia

Controls (without a history of TBI):

History of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia

Sexes Eligible for Study: All
50 Years to 95 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01891383
ERMS# 12lO9006
NEU-92-1855 ( Other Identifier: USUHS )
No
Not Provided
Not Provided
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
University of California, San Francisco
Principal Investigator: Ramon Diaz-Arrastia, M.D., Ph.D. Uniformed Services University of the Health Sciences
Principal Investigator: Kristine Yaffe, MD University of California, San Francisco
Uniformed Services University of the Health Sciences
December 2015